E-POLY 40MM +3 MAXROM LNR SZ24
Received Mar 14, 2018 · Event occurred Aug 11, 2011
Report 0001825034-2018-01788 · MDR key 7339122
Device
Generic name
Prosthesis, Hip
Manufacturer
Zimmer Biomet, Inc.Model number
N/ACatalog number
EP-108424
Lot number
878960
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
64 YR
- Blood Loss
- Blood Loss
Narrative
Additional Manufacturer Narrative
(B)(4). MEDICAL DEVICES: 11-301303, ARCOS CON SZ C STD 60MM, 163470, S001140, SELEX/MAGNUM MOD HD 40MM STD, 626430. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 01787, 0001825034 - 2018 - 01789. REMAINS IMPLANTED.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLOOD LOSS OF 1400 ML DURING A STAGE II REVISION PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Additional Manufacturer Narrative
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: (B)(4), SELEX/MAGNUM MOD HD 40MM +3 LOT# 971510; ITEM# (B)(4), BI-METRIC POR FMRL 9.0X250MML, LOT# 384650. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS WHICH INDICATED ESTIMATED BLOOD LOSS WAS ABOUT 1400 ML DURING PROCEDURE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.